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Methylphenidate Hydrochloride
Methylphenidate Hydrochloride recalls: 13 FDA reports
Recalls involving Methylphenidate Hydrochloride. What was wrong with each batch, and how the FDA graded the risk.
13Reports
0Class I
1Ongoing
2024-07-10Most 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
By year reported
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.
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured fo
D-0579-2024 · Class II · reported 2024-07-10 · Terminated
- Why it was recalled
- Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
- Product
- Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
- Where it went
- Nationwide in the USA
- How much
- 10,448 100-count bottles
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laborat
D-0940-2023 · Class II · reported 2023-08-02 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Metal embedded in a tablet.
- Product
- Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.
- Where it went
- Nationwide
- How much
- 7313 bottles
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Ph
D-0573-2022 · Class II · reported 2022-03-02 · Ongoing
- Why it was recalled
- Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
- Product
- Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01
- Where it went
- Nationwide in the USA
- How much
- 2220 100-count bottles
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharma
D-0837-2020 · Class II · reported 2020-02-19 · Terminated
- Why it was recalled
- CGMP deviations: Product bottle may be absent of desiccant.
- Product
- Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01
- Where it went
- USA Nationwide
- How much
- 17,436 bottles
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharma
D-0836-2020 · Class II · reported 2020-02-19 · Terminated
- Why it was recalled
- CGMP deviations: Product bottle may be absent of desiccant.
- Product
- Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01
- Where it went
- USA Nationwide
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laborato
D-0581-2018 · Class III · reported 2018-03-14 · Terminated
- Why it was recalled
- Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
- Product
- Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
- Where it went
- Nationwide in the USA
- How much
- 19,664 100-bottles
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laborat
D-0110-2018 · Class III · reported 2017-12-27 · Terminated
- Why it was recalled
- Subpotent Drug
- Product
- Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10
- Where it went
- Nationwide
- How much
- 10064 bottles
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laborato
D-0111-2018 · Class III · reported 2017-12-27 · Terminated
- Why it was recalled
- Subpotent Drug
- Product
- Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
- Where it went
- Nationwide
- How much
- 9919 bottles
Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceutica
D-1227-2014 · Class III · reported 2014-04-16 · Terminated
- Why it was recalled
- Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
- Product
- Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901, Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0440-05
- Where it went
- Nationwide and Puerto Rico
- How much
- 10,930 Bottles
Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceutica
D-1228-2014 · Class III · reported 2014-04-16 · Terminated
- Why it was recalled
- Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
- Product
- Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901 Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0441-05
- Where it went
- Nationwide and Puerto Rico
- How much
- 10,781 bottles
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEU
D-849-2013 · Class II · reported 2013-08-14 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
- Product
- Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
- Where it went
- Nationwide
- How much
- 7,579 bottles
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEU
D-847-2013 · Class II · reported 2013-08-14 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
- Product
- Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
- Where it went
- Nationwide
- How much
- 16,293 bottles
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEU
D-848-2013 · Class II · reported 2013-08-14 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
- Product
- Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01
- Where it went
- Nationwide
- How much
- 13,478 bottles
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.
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