Enalapril Maleate recalls: 6 FDA reports
Recalls involving Enalapril Maleate. What was wrong with each batch, and how the FDA graded the risk.
6Reports
0Class I
5Ongoing
2026-05-13Most 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.
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Lab
D-0520-2026 · Class II · reported 2026-05-13 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
- Product
- Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
- Where it went
- Nationwide in the USA
- How much
- 675 bottles
Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Indu
D-1177-2022 · Class II · reported 2022-07-13 · Ongoing
- Why it was recalled
- CGMP Deviations
- Product
- Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA.
- Where it went
- Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
- How much
- 1,471 bottles
Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Indus
D-1179-2022 · Class II · reported 2022-07-13 · Ongoing
- Why it was recalled
- CGMP Deviations
- Product
- Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
- Where it went
- Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
- How much
- 31,260 bottles
Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Indust
D-1178-2022 · Class II · reported 2022-07-13 · Ongoing
- Why it was recalled
- CGMP Deviations
- Product
- Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
- Where it went
- Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
- How much
- 9,058
Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Indus
D-1180-2022 · Class II · reported 2022-07-13 · Ongoing
- Why it was recalled
- CGMP Deviations
- Product
- Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
- Where it went
- Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
- How much
- 1,424 bottles
Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Ste
D-0019-2015 · Class III · reported 2014-10-22 · Terminated
- Why it was recalled
- Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
- Product
- Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187-0141-90 10 mg 30 ct - NDC 0187-0142-30 10 mg 90 ct - NDC 0187-0142-90 10 mg 1000 ct - NDC 0187-0142-10 20 mg 30 ct - NDC 0187-0143-30 20 mg 90 ct - NDC 0187-0143-90 20 mg 1000 ct - NDC 0187-0143-10 NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles
- Where it went
- Nationwide
- How much
- 205,853 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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