thejoe
ULTRAtab Laboratories, Inc.
ULTRAtab Laboratories, Inc.: 34 FDA recall reports
Every drug recall the FDA has published for ULTRAtab Laboratories, Inc.. The fault, and how the agency graded it.
34Reports
0Class I
0Ongoing
2022-02-16Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-
D-0536-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 6,249,082 tablets
Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland,
D-0547-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 990,197 tablets
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAt
D-0528-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 14,566,510 tablets
Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC
D-0541-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 3,050,308 tablets
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highla
D-0552-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 14,066,434 tablets
Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY ND
D-0540-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 3,052,313 tablets
Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland
D-0549-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 452,038 tablets
4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL
D-0524-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 19,103,287 tablets
HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRA
D-0538-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 50,585,623 tablets
Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container,
D-0553-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 25,769,495 tablets
Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY
D-0539-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 3,349,387 tablets
DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Lab
D-0554-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 8,727,657 tablets
Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland,
D-0535-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 6,215,512 tablets
Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highla
D-0550-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 1,585,375 tablets
Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Con
D-0526-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 639,729 tablets
Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laborat
D-0544-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 7,297,709 tablets
Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland,
D-0543-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 5,923,518 tablets
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAt
D-0523-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 33,758,436 tablets
Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC
D-0534-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 2,048,941 tablets
Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-
D-0532-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 16,429,211 tablets
Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., High
D-0546-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 7,983,360 tablets
Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, N
D-0545-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 4,531,580 tablets
APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
D-0531-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 3,677,483 tablets
APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highlan
D-0548-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 6,380,282 tablets
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Labor
D-0525-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 1,798,048 tablets
Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY
D-0542-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 1,527,203 tablets
Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Hi
D-0555-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 37,464,418 tablets
Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laborato
D-0527-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 917,304 tablets
Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-
D-0533-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 3,667,885 tablets
APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959
D-0529-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- CGMP Deviations
- Product
- APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
- Where it went
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- How much
- 451,123 tablets
Showing the 30 most recent of 34. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All drug recalls