CLASS II Drug recall · Reported 10 Feb 2016 · FDA Enforcement Report
Lyrica (pregabalin) capsules, 75 mg recalled by Pfizer
Pfizer is recalling Lyrica (pregabalin) capsules, 75 mg, distributed nationwide in the US. The recall was initiated on 11 Jan 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0649-2016
- FDA event ID
- 73043
- Recalling firm
- Pfizer, New York, NY
- Brand
- Lyrica
- Manufacturer
- Parke-Davis Div of Pfizer Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2016
- FDA classified
- 1 Feb 2016
- Reported
- 10 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 11 Jan 2016 | Recall initiated by company | |
| 1 Feb 2016 | Classified by FDA | +21 days |
| 10 Feb 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Product as listed by the FDA
Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Which lots are affected?
Lot #: M07862, Exp 05/2018; M07865, Exp 06/2018
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 73043| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lyrica (pregabalin) capsules, 50 mg recalled by PfizerLyrica | Pfizer | Other | Nationwide |
More recalls from Pfizer
All 127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dopamine HCl Inj., USP, 200 mg/ (40 mg/mL) Single-dose recalledDopamine Hydrochloride | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ (0.1 mg/mL) recalled | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
Other Pregabalin recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pregabalin Capsules 50mg recalled by Rising Pharma HoldingPregabalin | Rising Pharma Holding | Packaging Defects | Nationwide |
| Drug | CLASS II | Pregabalin Capsules, 50 mg recalled by Sun Pharmaceutical IndustriesPregabalin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Pregabalin Capsules 300mg recalled by Cardinal HealthPregabalin | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Lyrica (pregabalin) capsules, 50 mg recalled by PfizerLyrica | Pfizer | Other | Nationwide |
| Drug | CLASS II | Pregabalin, Capsule, 25 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |